Data from 12- and 24-Week Pivotal Studies Selected to Be Presented
at The North American Menopause Society Annual Meeting

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Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical
Co., Inc., today announced positive results from two multicenter, double-blind,
randomized, placebo-controlled Phase 3 clinical studies evaluating low-dose
mesylate salt of paroxetine (LDMP; 7.5 mg/day) for the treatment of moderate
to severe vasomotor symptoms (VMS) associated with menopause. Menopausal
VMS, which comprise hot flashes and night sweats, affect up to 80 percent
of women experiencing menopause, and many women report them as the most
bothersome symptoms related to the condition. The co-primary endpoints
of the studies evaluated weekly reductions in the frequency and severity
of VMS associated with menopause in patients taking LDMP versus placebo
at Week 4 and Week 12. The 24-week study achieved statistical significance
in all co-primary endpoints. The 12-week study also achieved statistical
significance for all co-primary endpoints, except for severity of VMS
symptoms at Week 12.

“If a patient is unable or unwilling to take hormone therapy, which
is currently the only FDA-approved treatment option for menopausal hot
flashes and night sweats, these symptoms often go untreated,” said James
A. Simon, MD, CCD, NCMP, FACOG, clinical professor of obstetrics and
gynecology at the George Washington University School of Medicine, Washington,
D.C. and study investigator. “The approval of a nonhormonal therapy would
be an important milestone to expand available options for women seeking
treatment for VMS associated with menopause.”

Phase 3 data from 12-week and 24-week studies are being presented at
the 23rd Annual Meeting of The North American Menopause Society on October
4 and 5, respectively. The 24-week study was one of four abstracts selected
for oral presentation at the meeting’s Top Scoring Scientific Abstract
Session.

"Women often report hot flashes as the most common symptom associated
with menopause, yet, there has been a decline in the use of hormone therapy
among women seeking treatment for menopausal VMS,” said Andrew M. Kaunitz,
MD, professor and associate chair, department of obstetrics and gynecology,
University of Florida College of Medicine, Jacksonville and study investigator.
“LDMP was specifically developed for the treatment of menopausal VMS.
It appears to be effective and well tolerated, and, if approved by the
FDA, it could be the first nonhormonal option available for women.”

In August 2012, Noven Pharmaceuticals, Inc., submitted a New Drug Application
to the Food and Drug Administration (FDA) for LDMP for the treatment
of moderate to severe VMS associated with menopause.

Safety and Efficacy of Low-dose Mesylate Salt of Paroxetine for the
Treatment of Vasomotor Symptoms Associated with Menopause: A 24-Week,
Randomized, Placebo-controlled Phase 3 Study: (Oral Presentation at the
23rd Annual Meeting of The North American Menopause Society – 11:30-11:45
a.m. ET – October 5, 2012 – Top Scoring Abstracts Session)

This 24-week, multicenter, double-blind, randomized, placebo-controlled
study of LDMP evaluated weekly reductions in the frequency and severity
of moderate to severe VMS in 568 women age 40 and older with an average
of more than 7 to 8 moderate to severe hot flashes daily or 50-60 moderate
to severe hot flashes per week for at least 30 days prior to the study.

Women who met eligibility criteria were randomized to receive either
7.5 mg of LDMP or placebo once daily at bedtime for 24 weeks. Participants
recorded the number and severity of hot flashes in electronic daily diaries.
Co-primary endpoints were mean weekly changes in the frequency of moderate
to severe VMS from baseline to Weeks 4 and 12 and mean weekly changes
in severity of moderate to severe VMS from baseline to Weeks 4 and 12.
A responder analysis was conducted to evaluate persistence of treatment
benefit at Week 24, where a responder was defined as a subject with greater
than or equal to a 50 percent reduction in VMS frequency from baseline
to Week 24.

Results also showed that mean weekly reductions in VMS severity were
also significantly greater for LDMP than for placebo at Week 4 (–0.089
and –0.056, respectively; p=0.0452) and at Week 12 (–0.123 and –0.067,
respectively; p=0.0114).

Hot flash composite scores were also used to evaluate hot flash severity
of moderate and severe menopausal VMS. Mean weekly reductions in VMS
hot flash composite scores (moderate and severe) from baseline were significantly
greater for LDMP than placebo at Week 4 (–76.08 and –49.50 respectively;
p<0.0001) and at Week 12 (–97.73 and –70.20 respectively; p=0.0001).

The most commonly reported adverse events in the LDMP treatment group
were nausea and bronchitis.

Safety and Efficacy of Low-dose Mesylate Salt of Paroxetine for the
Treatment of Vasomotor Symptoms Associated with Menopause: A 12-Week,
Randomized, Placebo-controlled Phase 3 Study (Poster Presentation at
the 23rd Annual Meeting of The North American Menopause Society – 6-7
p.m. ET – October 4, 2012)

This 12-week, multicenter, double-blind, randomized, placebo-controlled
study of LDMP evaluated weekly reductions in the frequency and severity
of moderate to severe VMS in 606 women age 40 and older with an average
of more than 7 to 8 moderate to severe hot flashes daily or 50-60 moderate
to severe hot flashes per week for at least 30 days prior to the study.

Women who met eligibility criteria were randomized to receive either
7.5 mg of LDMP or placebo once daily at bedtime for 12 weeks. Participants
recorded the number and severity of hot flashes in electronic daily diaries.
Co-primary endpoints were mean weekly changes in the frequency of moderate
to severe VMS from baseline to Weeks 4 and 12 and mean weekly changes
in severity of moderate to severe VMS from baseline to Weeks 4 and 12.

Results also showed that mean weekly reductions in VMS severity from
baseline were significantly greater for LDMP than placebo at Week 4 (–0.09
and –0.05, respectively; p=0.0048) but not at Week 12 (–0.10 and –0.09,
respectively; p=0.2893).

Hot flash composite scores were also used to evaluate hot flash severity
of moderate and severe menopausal VMS. Mean weekly reductions in VMS
hot flash composite scores (moderate and severe) from baseline were significantly
greater for LDMP than placebo at Week 4 (–85.51 and –60.83 respectively;
p<0.0001) and at Week 12 (–111.9 and –96.85 respectively; p=0.0063).

The most frequently reported adverse events in the LDMP group were dizziness
and fatigue.

About Menopause
Menopause is a natural part of every woman’s life and
is better understood and more openly discussed than it was years ago.
The average age of a woman entering menopause is 51 years old. Menopause
is typically confirmed when a woman has missed her menstrual periods
for 12 consecutive months. During perimenopause, the transition period
before a woman reaches menopause, estrogen levels gradually decline and
periods may become irregular. The severity of symptoms associated with
going through menopause varies from woman to woman. Symptoms associated
with menopause include hot flashes, night sweats and vaginal dryness
and atrophy, with hot flashes being the most common symptoms. Because
the journey is unique for each woman, it is important for women going
through menopause to have a thorough discussion about the transition
with their doctors and determine if treatment is appropriate.

About LDMP
LDMP, formerly referred to as Mesafem, is an oral low-dose
nonhormonal therapy (7.5 mg once daily taken at bedtime) specifically
developed by Noven for the treatment of moderate to severe VMS associated
with menopause. More information about clinical trials involving LDMP
can be found at www.clinicaltrials.gov. If approved by the FDA, LDMP
may be a potential nonhormonal therapy option for women seeking treatment
for VMS associated with menopause. Hormone replacement therapy is currently
the only FDA-approved treatment for VMS. If patients are not appropriate
for or not interested in initiating or continuing hormone therapy, these
symptoms often go untreated.

About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged
in the research, development, manufacturing, marketing and sale of
prescription pharmaceutical products. Noven is committed to developing
and offering products and technologies that meaningfully benefit
patients, its customers and its industry partners. Noven is a stand-alone
operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co.,
Inc., and serves as Hisamitsu’s U.S. growth platform in prescription
pharmaceuticals. For more information about Noven, visit www.noven.com.
For information about Hisamitsu, visit www.global.hisamitsu.